Defective Medical Devices

Many of today’s medical devices have evolved from where they were decades ago. Such changes come with risks. Based on those potential risks, the U.S. Food & Drug Administration (FDA) may issue warnings about possible dangers to your health and may order medical devices removed from the market.(1)

According to the U.S. Government Accountability Office, sales for 102 medical device companies in the United States increased 43% between 2005 and 2014.(2) Those numbers may give medical device manufacturers a reason to cheer. A good profit margin always boosts the morale of CEOs.

However, if you have been injured by a medical device, someone else’s profit margin may be the last thing on your mind. What you need right now is for someone to listen to you and take you seriously. You need someone who can provide you with dependable legal guidance and assistance. That is where Weitz & Luxenberg comes in.

Defective Medical Device Lawsuits

If you have been injured by a faulty medical device, Weitz & Luxenberg may be able to help. Our firm has 30 years of experience in complex, large-scale, medical-related litigation. Over the years, we have represented hundreds of thousands of people. Our Weitz & Luxenberg lawyers are prepared to guide you through the legal process.

Weitz & Luxenberg is a national law firm. No matter where you live in the U.S. or which manufacturer made the medical device that harmed you, we are prepared to represent you and stand up to corporations or medical manufacturers of any size.

We do not back down from global medical manufacturers that have produced and distributed faulty, harmful medical devices. We stand by our clients, and we guarantee you can depend on us for solid, experienced guidance and legal counsel.

Defective Medical Device Lawyers

Not all medical devices are required to undergo comprehensive scientific and regulatory review before being marketed and sold in the United States. This is because a medical device manufacturer who believe that its device is “substantially equivalent” to a predicate device (one that has been cleared by the FDA or marketed before 1976) can apply to enter the U.S. market under the FDA 510(k) process. The 510(k) process bypasses the rigorous FDA Premarket Approval (PMA) process to evaluate the safety and effectiveness of new Class III medical devices. The purpose of a FDA 510(k) submission is to demonstrate that a device is “substantially equivalent” to a predicate device. Unlike the PMA process, which requires a manufacturer to present scientific evidence to assure that the device is safe and effective for its intended use(s), the 510(k) application submitter merely compares and contrasts its device with one or more predicate devices, explaining why any differences between the new and predicate device should not affect functioning. Clinical studies are usually not required for a 510(k) submission. Depending on the type of 510(k), the law gives the FDA either 30 or 90 days to decide “whether the device is equivalent to a device already” approved for distribution, ask further questions, or reject the application.(3)

For a free consultation and more information about your legal options, please contact us today.

Although the FDA continues to monitor 510(k) medical devices after approval, such as through the FDA’s MAUDE (Manufacturer and User Facility Device Experience) database,(4) manufacturers are primarily responsible for tracking, following-up on, and reporting adverse events occurring in patients using their products.

Sometimes, FDA approves a medical device and then growing clinical evidence demonstrates the serious harm the device causes when brought to market without being adequately tested by manufacturers for human safety.(5) (6)

If you have suffered medical complications linked to a faulty medical device, you have a right to seek compensation from the device manufacturer. At Weitz & Luxenberg, our defective medical device lawyers are here to help.

Currently, we are accepting clients who have been harmed by certain types of:

Hip, knee, and shoulder implants

Retrievable IVC filters

Surgical hernia mesh

Heater-cooler units used for cardiopulmonary bypass

If you have been injured by a defective medical device, Weitz & Luxenberg wants to hear from you. We offer a free consultation. One of our attorneys can help you review and understand your legal options.

Medical Device Recalls

Although many of the medical devices we use at home, buy in stores, or see in a medical facility have been approved by the FDA, that does not necessarily mean they are safe. Manufacturers frequently issue medical device recalls for products that were approved by the FDA.

You may hear about defective medical device recalls by watching or reading the news. In addition, you can search the FDA’s database for the most updated information.

Medical Device Recalls

Although many of the medical devices we use at home, buy in stores, or see in a medical facility have been approved by the FDA, that does not necessarily mean they are safe.

According to the FDA, the agency “posts summaries of information about the most serious medical device recalls.” Devices are included in those posts when the FDA believes that there is the possibility “they could cause serious health problems or death.”(7)

Whether or not a manufacturer has recalled a medical device, you still have the right to look into taking legal action if you have been injured by a faulty medical device. At Weitz & Luxenberg, we stay on top of all significant FDA medical device safety announcements and remain informed about all related legal proceedings.

If you believe you have suffered medical complications due to any kind of medical device, we encourage you to call us for a free consultation. We will be happy to discuss the legal options available to you.

Medical Device Complications: Metal-on-Metal Hip Implants

Total hip replacement (arthroplasty) is an orthopedic intervention. Some hip systems have been made out of all-metal materials.(8) It is estimated that more than one million people around the world have metal-on-metal (MoM) hip implants.(9)

Several models of all-metal hip implants have shown a higher-than-anticipated failure rate, leading to serious injuries or medical complications for patients. In response, the FDA has issued a number of safety communications and several recalls have been initiated.(10) (11)

Corrosion or wear between metal-on-metal parts can release chromium, cobalt, and titanium ions into the body. Metal debris can damage tissue and lead to a condition called metallosis – which can starve tissue of oxygen and lead to cell death, potentially causing a host of problems.(12) (13) Other complications from defective metal-on-metal hip implants may include:

Correcting these issues often requires revision surgery, which subjects a patient to further risks and possible complications.

In recent years, a number of patients have experienced severe complications following metal-on-metal hip replacement surgery. In response, Weitz & Luxenberg has taken legal action against hip implant manufacturers.

In 2014, Weitz & Luxenberg Practice Group Co-Chair Ellen Relkin served a key role in multidistrict litigation against DePuy Orthopaedics, a subsidiary of Johnson & Johnson, regarding its defective articular surface replacement (ASR) metal-on-metal hip implant. Ms. Relkin helped secure a $2.5 billion settlement against DePuy on behalf of patients who had received the faulty implant.

More recently, in 2016, juries in separate trials sided against DePuy regarding its Pinnacle hip implant when it was used in a metal-on-metal configuration. They have awarded more than one billion dollars across multiple suits to plaintiffs related to defective Pinnacle hip implants. DePuy faces thousands of additional lawsuits pending nationwide regarding its defective Pinnacle hip.(17)

Smith & Nephew Hip Implant Components

A growing body of medical literature is linking the Smith & Nephew EMPERION hip implant system to sudden fractures of the implant. In addition to discussing high rates of failure due to implant fracture, the Australian Joint Registry has identified the Emperion as having a significantly higher percentage of revisions than other primary total hip replacements, with more than two times the risk of revision occurring with the Emperion.(18) (19) (20) (21)

Weitz & Luxenberg continues to accept cases involving faulty Smith & Nephew EMPERION hips along with Modular SMF and Modular REDAPT models, the latter of which have been recalled due to potential for higher risk of revision.(22) If you suffered complications after receiving one of these Smith & Nephew hip implants, we encourage you to contact us.

Weitz & Luxenberg’s Ellen Relkin is credited with playing a key role in this settlement.

Stryker Recalls LFIT V40 Femoral Head

In August 2016, Stryker recalled certain lots and sizes of its LFIT Anatomic Cobalt Chromium V40 Femoral Heads (LFIT V40 femoral heads) due to the company receiving complaints of taper lock failure.(24) Taper locks are located at the junction where the femoral head attaches to the stem of the hip implant.

In April 2017, Panel on Multidistrict Litigation agreed to consolidate more than two dozen lawsuits pending against Stryker into a multidistrict litigation in the District of Massachusetts.(25)

Plaintiffs claim the LFIT V40 femoral heads can release toxic and corrosive cobalt into people implanted with the devices, potentially necessitating revision surgery. The complaints state the corrosive effects can be severe enough to cause the femoral heads to break off and become separated from the rest of the implant.(26)

Wright Medical Agrees to Pay $240 Million

In 2016, Wright Medical Group agreed to settle more than 1,200 lawsuits over its metal-on-metal Conserve, Lineage, and Dynasty hip implants.(27) As co-lead counsel, Weitz & Luxenberg’s Ellen Relkin again played a role in crafting the $240 million settlement agreement.

A Class 1 recall is the most serious. The FDA issues a Class 1 recall in situations “in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”(30)

In 2015, MicroPort’s Profemur Neck Varus/Valgus CoCr 8 Degree modular neck was voluntarily recalled, with the FDA classifying this as a Class 1 recall. Originally, Wright Medical designed and manufactured this modular neck, but Wright’s OrthoRecon Business was acquired by MicroPort Scientific Corporation in June, 2013.(28) (29)

A Class 1 recall is the most serious. The FDA issues a Class 1 recall in situations “in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”(30)

The FDA’s safety alert warned that the modular neck could fracture, requiring emergency revision surgery. The FDA said a sudden fracture “could lead to neurovascular damage, hematoma, hemorrhage, and even death.”(31)

If you have been injured by a Wright Medical Conserve, Lineage, or Dynasty hip implant or by a Profemur Neck Varus/Valgus CoCr 8 Degree modular neck requiring revision surgery, you may want to consult an experienced attorney. The attorneys at Weitz & Luxenberg offer a free consultation. We can help you consider your legal options.

You May Have Medical Device Complications with Knee Implants

Following knee implant surgery, some pain is to be expected. However, some problems and complications may be serious.(32)

Infection

If your implant has become infected, you may need to have a revision, or corrective, surgery to replace the infected joint and clear the infection.

Dislocation

Suffering from a dislocation “can cause sudden pain and inability to walk.” If this occurs, you may need to visit the emergency room.

Loosening

Whether shortly after surgery or over time, loosening of the implant may cause pain. A revision surgery may be necessary.

More recently, in 2015, Zimmer Biomet voluntarily recalled more than 11,000 components used in the Zimmer Persona Knee Personalized Knee System after complaints of loosening and radiolucent lines. The FDA categorized the recall as Class 2.(36)

If you had a Zimmer Persona Knee Personalized Knee System implanted and required revision surgery, we encourage you to call Weitz & Luxenberg. We offer a free consultation and can offer guidance about your legal options. Call us if you have had any of these complications:

Loosening of the implant

Pain

Early implant failure

Revision of the knee

Shoulder Implants May Suffer from Medical Device Complications

The complications you may suffer from after undergoing shoulder implant surgery with a defective shoulder device are similar to those of defective knee implants. These complications include:(40)

Zimmer Biomet Recalls Comprehensive Reverse Shoulder

On December 15, 2016, Zimmer Biomet voluntarily recalled over 3,600 of its Comprehensive Reverse Shoulder System devices because the devices were fracturing at a higher rate than the labeling indicated. The FDA categorized this recall as Class 1, which is the most serious type of recall.(41)

Fractures

Fractures are serious because they “may result in revision surgeries.” Revision surgeries are serious because they “could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.”(42)

Fractures are serious because they “may result in revision surgeries.” Revision surgeries are serious because they “could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.”(42)

If you have experienced any complications after receiving Zimmer Biomet’s Reverse Shoulder System, we urge you to contact us. Weitz & Luxenberg is offering a free consultation to anyone who has experienced fracture of implanted device requiring revision surgery.

Retrievable IVC Filters Defective Medical Device Lawsuits Filed

IVC filters are tiny medical implants inserted into the primary vein (the inferior vena cava)(43) that returns blood to the heart from the lower half of the body. The goal is to trap a blood clot so that it cannot travel to the lungs, where it could lead to a pulmonary embolism (PE).(44) A PE “is a blockage in one of the pulmonary arteries” in the lungs.(45)

According to the FDA, retrievable IVC filters should be removed after the threat of a clot has passed, given that these devices can potentially lead to serious, even life-threatening, complications:(46)

Fracturing of the device

Migration of broken parts or the entire device

Perforation of blood vessels

Embolization (movement of the device or fractured pieces) to other organs

The U.S. Judicial Panel on Multidistrict Litigation has combined the lawsuits against each company into separate multidistrict litigation suits(49). Jonathan Sedgh of Weitz & Luxenberg’s Defective Drugs and Devices Unit is serving on the Plaintiffs’ Steering Committee for the Cook Medical IVC Filters MDL, in the Southern District of Indiana.(50) (51)

“The FDA has determined that long-term use of retrievable IVC filters may pose dangerous risks,” Mr. Sedgh said. “And the negligent manufacturers should do the right thing and compensate those who were injured.”

If you suffered complications from a retrievable IVC filter, or a relative has died after a retrievable IVC filter failed, you may be able to seek compensation for medical expenses, lost wages, and other costs. For a free case review, contact Weitz & Luxenberg.

Medical Device Complications: Surgical Hernia Mesh

According to the FDA, one million hernia repair procedures are performed each year in the United States.(52) Although the FDA has approved the surgical hernia mesh devices on the market today, the agency has issued warnings about possible complications, and notes that several meshes have been recalled.(53)

Complications of surgical mesh used in hernia repair include:(54)

Adverse reactions to the mesh itself including pain, infection, and hernia recurrence

Adhesions — when parts of the intestines stick to the mesh or each other

Bowel obstruction

Tissue perforation

Damage to organs, blood vessels, and nerves near the mesh

Mesh migration

Mesh shrinkage (contraction)

Weitz & Luxenberg is accepting cases of complications occurring with these surgical meshes used in hernia repair:

Some complications reported with these brands include:(55) (56) (57) (58)

Loss of coating on mesh after implantation

Failure of mesh to incorporate/adhere to tissues

Bowel obstructions

Mesh failure

Perforation of the intestines

Migration from the surgical site

Seromas – pockets of fluid that build up under the skin

Revision, or corrective, surgery

Infection

Chronic pain

Hernia recurrence

If you have suffered medical device complications requiring hospitalization or corrective surgery due to problems with the mesh used in your hernia repair, you may be entitled to compensation for medical costs and other expenses. Weitz & Luxenberg invites you to contact the firm for a free consultation to help you understand your legal options.

Sorin Stockert 3T Heater-Cooler Device Complications

Heater-cooler medical devices, such as the Sorin Stockert 3T Heater-Cooler System, are often used, as the FDA describes, “during cardiothoracic surgeries… to warm or cool a patient… Heater-cooler devices have water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits… there is the potential for contaminated water to… aerosolize, transmitting bacteria through the air and through the device’s exhaust vent into the environment and to the patient.”(59)

In recent years, the FDA has issued warnings about heater-cooler devices in an effort to decrease patients’ risk of developing certain types of infections after undergoing procedures, such as open-heart surgery, that require cardiopulmonary bypass. The FDA is continuing “to evaluate the causes and risk factors for transmission of microbial agents associated with heater-cooler devices.”(60) (61)

The Centers for Disease Control and Prevention (CDC) has also studied and weighed in on this problem, warning that hospitals should “take action” and patients should “seek care if ill” after having open heart or open chest surgery and begin experiencing symptoms of infection such as “night sweats, muscle aches, weight loss, fatigue, or unexplained fever.”(62)

If you developed certain types of infections or infection-related complications after being exposed to a Sorin Stockert 3T heater-cooler medical device during cardiothoracic surgical procedures or treatments, we encourage you to contact us. Specifically, we are interested in hearing from you if you developed an infection with nontuberculous mycobacteria, including: M. abscessus, M. avium, M. avium intracellulare, M. chimaera, M. fortuitum, M. intracellulare.

If you have contracted an infection linked to a Sorin Stockert 3T heater-cooler device used during your open-chest surgery, Weitz & Luxenberg may be able to help you. We urge you to contact us. We offer a free initial consultation and can advise you of possible compensation and legal actions.

FDA Warns About Dangers of Power Morcellators

Power morcellators are surgical instruments with small blades on the end. In gynecological surgeries, such as hysterectomies (removal of the uterus) and myomectomies (removal of fibroids), surgeons often used these devices with rapidly spinning blades on the tip to mince tissue into tiny pieces to remove it through the small incisions made during laparoscopic surgery.(63)

Although the FDA approved power morcellators for use in laparoscopic gynecological surgeries in 1991, considerable medical literature and case studies exist regarding the ability of these devices to slice up previously undetected, aggressive cancer cells or tumors and spread them throughout the abdomen, accelerating the rate of a patient’s disease and likely hastening her demise.(64)

After holding an Advisory Committee meeting the FDA released labeling guidelines for power morcellator manufacturers, including contraindications against use in women who are “candidates for en bloc tissue removal” and a black box warning stating the use of power morcellators in hysterectomy or myomectomy “may spread cancer, and decrease the long-term survival of patients.”(65)

Defective Medical Device Lawyers: How Weitz & Luxenberg Can Help

We have represented thousands of clients across the country, winning more than $17 billion on their behalf.

As a national law firm with more than 30 years of experience winning complex, large-scale, defective medical device lawsuits, Weitz & Luxenberg is prepared to take on the challenging cases. We have represented thousands of clients across the country, winning more than $17 billion on their behalf.

If you have been injured by a medical device, we urge you to call us now. We offer a free consultation and can help you consider your legal options.

You can reach us by phone at (855) 274-5624 or fill out the form on this page. One of our representatives will contact you shortly.

Although a past record does not guarantee future success, Weitz & Luxenberg has the experience and resources necessary to stand up to the large manufacturers of defective medical devices.

U.S. Government Accountability Office. (2015, June 30). Medical Device Companies: Trends in Reported Net Sales and Profits Before and After Implementation of the Patient Protection and Affordable Care Act. Retrieved from http://www.gao.gov/products/GAO-15-635R

The Wall Street Journal. (2014). How Morcellation, a Common Procedure, Spread Cancer in Hysterectomy Patients. Retrieved from http://www.wsj.com/morcellation

U.S. Government Accountability Office. (2017, February). Medical Devices. Cancer Risk Led FDA to Warn Against Certain Uses of Power Morcellators and Recommend New Labeling. Retrieved from http://www.gao.gov/assets/690/682573.pdf

U.S. Government Accountability Office. (2017, February 7). Medical Devices: Cancer Risk Led FDA to Warn Against Certain Uses of Power Morcellators and Recommend New Labeling. Retrieved from https://www.gao.gov/products/GAO-17-231

The Wall Street Journal. (2014). How Morcellation, a Common Procedure, Spread Cancer in Hysterectomy Patients. A Wall Street Journal investigation into a risky and sometimes deadly surgical device. Retrieved from http://www.wsj.com/morcellation

U.S. Government Accountability Office. (2017, February). Medical Devices. Cancer Risk Led FDA to Warn Against Certain Uses of Power Morcellators and Recommend New Labeling. Retrieved from http://www.gao.gov/assets/690/682573.pdf

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For a free consultation and more information about your legal options, please contact us today.